Abstract

Commentary on the Orvieto and Seifer Editorial on Biosimilar "r-FSH-bearing" Medicines in Reproductive Biology and Endocrinology

The approval of two biosimilar follitropin alfa-bearing medicines triggered a debate among reproduction biology specialists, as to their risk-to-benefit balance. Controversies were discussed by Orvieto and Seifer in their Editorial “Biosimilar FSH preparations-are they identical twins or just siblings?” published in Reproductive Biology and Endocrinology in 2016. This commentary is intended to challenge some of the authors’ statements on the clinical uncertainty attributed to biosimilars. Of note, as a key argument, Orvieto and Seifer express their concern over a potential therapeutic impact of existing physicochemical differences between biosimilars and reference products. Put in context, physicochemical variability is intrinsic to any biologically-sourced medicine. Indeed, based on the experience on batch-to- batch heterogeneity of original biomedicines, minor molecular changes in non-essential attributes may be clinically acceptable. Therefore, the stringent science-based comparability exercise between a biosimilar candidate and a reference product is designed to show that those potential minor physicochemical differences do not significantly alter safety and efficacy. Hence, evidence supports that biosimilars, such as Bemfola® and Ovaleap®, and their original counterpart, Gonal-f®, share essentially the same active substance. Physicians and patients should thus be reassured that follitropin alfa-bearing biosimilars approved under the EMA standards provide a high quality alternative to original products.


Author(s):

Fernando de Mora



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